April 28, 2022, Shanghai, China: Maxinovel Pharmaceuticals Co., Ltd. (“Maxinovel” hereafter) announced dosing of first patient with MAX-40279, a novel multi-tyrosine kinase inhibitor developed by Maxinovel, in the global multi-center Phase II study (MAX-40279-005, NCT05130021) of 3rd line or above therapy for advanced colorectal cancer, at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
This study will evaluate the efficacy and safety of MAX-40279 in patients diagnosed with advanced colorectal cancer who have previously received standard chemotherapy combined with or without a monoclonal antibody. Prior to initiating this trial, Maxinovel has conducted multiple dose-escalation Phase I studies in Australia and China. Additionally, Maxinovel has reached agreement with Junshi Biosciences and Alphamab Oncology to collaborate on two Phase I studies, evaluating MAX-40279 combined with immune checkpoint inhibitor, Toripalimab (anti-PD-1 monoclonal antibody) or KN046 (anti-PD-L1/CTLA4 bispecific antibody) in solid tumors.
MAX-40279 is the first new molecular entity (NME) from the pipeline that has progressed to proof-of-mechanism/concept stage of clinical development. Multi-mechanisms are implicated in the antitumor effect of MAX-40279.  Preclinical studies have shown that MAX-40279 can inhibit varieties of receptor tyrosine kinases. Additionally, MAX-40279- can inhibit hematopoietic progenitor kinase 1 (HPK1) and relieve the negative regulation of HPK1 on T cell receptor (TCR) pathway. Furthermore, through translational research, Maxinovel scientists identified a potential biomarker, an adaptor protein that can bind to multiple tyrosine kinases, may be predictive of response to MAX-40279 treatment.

The medical lead of this study, Dr Yunlong Mo, commented: "With the establishment of chemotherapy combined with or without monoclonal antibodies as the standard 1st / 2nd lines, the survival of patients with advanced colorectal cancer has been greatly improved. However, currently, options for the 3rd line or above treating advanced colorectal cancer are very limited, and the clinical benefits need to improve. Based on the results of our previous study, MAX-40279 may be a future viable option."

"We appreciate the great support from our Leading PI, Professor Yanhong Deng & her study team at the Sixth Affiliated Hospital of Sun Yat-sen University as well as the collaborative effort from our clinical team, CRO and SMO colleagues to achieve this important milestone. This is the first global multi-center Phase II clinical study for Maxinovel.  It generates great momentum. We will continue to advance our pipeline with fast pace and high-quality standard." Said Rong Wang, the operation lead of the MAX-40279-005 study from Maxinovel.